Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

What Was Tested

The trial (not phased) is built around Oxytocin.

Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status.

Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help them provide better care for their patients and their fetuses.

It had two arms (groups): Routine Oxytocin (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Informed, written consent will be obtained.

At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope.

Patients will be randomized to one of four groups.

The bolus will be administered through a free-flowing wide open intravenous catheter until complete.

Who Took Part

Enrollment: 172 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18 and over. Healthy nulliparous or multiparous women. Term (\>36 week gestation). Spontaneous labor or spontaneous rupture of membranes. Request neuraxial analgesia.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: under 18 years old; presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia; use of chronic analgesic medications.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2014-04 with completion listed for 2021-09-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of Non-reassuring Fetal Heart Rate Tracings (time frame: Request for labor analgesia up to the first 60 minutes after the epidural placement).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 172 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.